VHA National Center for Patient Safety

Heater Cooler Hazard Summary

Additional information can be found on the CDC website:
http://www.cdc.gov/HAI/outbreaks/heater-cooler.html

Frequenly Asked Questions about the recent Heater Cooler Device (HCD) patient notification letter:

What is this notification about?
The VA notified you that you might have been put at risk for exposure to an infection because you had recent heart surgery where some of the equipment may have become infected during manufacturing.

How did this notification arise?
The equipment that this notification concerns is called a heater-cooler unit, which is connected to the heart-lung bypass machine that is used for heart surgery procedures.  The equipment is routinely cleaned after surgery using multiple steps.  However, the US FDA and CDC issued a national alert last month because several patients in Europe and the United States have become infected with a rare type of bacteria that was found in the heater-cooler machine and likely had been there since the time the machine was built. After consultation with experts, your VA facility leadership decided to alert all VA patients who may have come in contact with this equipment.

What steps are being taken to investigate this problem?
For any Veteran who had heart surgery over the last 5 years using this equipment, the VA facility was required to send a letter (or, in some cases, make a phone call) notifying the Veteran about the issue and advising them of their options to seek care at the VA.  For Veterans who have moved and no longer live near the VA where they had the heart surgery procedure performed, their closest VA would provide care.

What kind of germs or infections am I at risk for?
The bacterial infection we are concerned about would not usually cause symptoms for a while. The bacteria that has caused infection in relation to the heart surgery procedure is called Mycobacterium chimaera and is also referred to as nontuberculous mycobacteria or NTM. This does not mean you have tuberculosis. M. chimaera can cause damage to heart valves and other organs. Though the risk of transmission of these bacteria during your procedure is extremely low, it is VA policy to inform you anytime we know there is any risk at all. 

What kind of testing needs to be performed?
The way to tell if you are infected is to have your doctor evaluate you and see whether you might have any signs of infection with this bacterium. It might require a blood test or culture that looks for evidence of the bacteria in your body.  If you decide you want to be tested, VA will provide all necessary tests without any charges or co-payment.  Whether or not to have one or more of these tests is entirely up to you and whatever you decide will not affect your eligibility for care from the VA. 
Testing for NTM can be done with a simple visit to the lab to have your blood drawn once the order is put into the system.

When will I be told about the results of my blood tests?
After your VA provider does an evaluation and determines that testing is indicated, we will obtain the necessary culture samples or draw the blood today. You will not be charged a co-pay for that visit.  It can take approximately 6 weeks for the results to be available.   If you already have an appointment with a VA provider around that time you may choose to get the results of your test during that appointment.  Otherwise, we will get in contact with you when the test results are ready.  Before you leave today please verify that the contact information we have for you is current.

Do I need to get evaluated or tested today?
It is entirely up to you whether or not you get evaluated or tested.  Even if you decide not to get tested today, you can come back later and have the testing done at no charge or co-pay.  

Do I need to be tested more than once?
It can take up to 5 years for this infection to show symptoms. So we may need to repeat an evaluation or testing with another culture or blood draw in the future, particularly if you develop any symptoms that might be associated this infection.

Does this testing have any effect on the heart surgery procedure I had?
The answer is that it does not.  Even with the remote chance that you were exposed to this bacterium during your procedure, it would not affect the result. There would be no need to have the procedure repeated.

If I were to get this infection, is it treatable?
Yes, this infection can be treated with antibiotics, but usually requires a combination of different antibiotics and treatment is prolonged, and can take several months.

What are the chances of me passing on this infection to someone else?
This bacterial infection is not transmitted by routine, non-intimate contact such as shaking hands or hugging, nor does coughing or sneezing spread them.  As far as we know, it cannot be spread through close personal contact such as sex or sharing needles used for injecting any kind of drug (whether legally obtained or not).  Of course, if you are not infected this is not a concern, but if you were to find out that you were infected a part of your care would be explaining how you can avoid passing the infection to others.

What are my legal rights?
Any legal rights you have are not affected by your decision to have this evaluation or testing done or not done.  The purpose of providing this information is to give you the clinical information you need to decide about getting evaluated and tested.  As mentioned earlier, whatever you decide to do about testing will not affect your eligibility for VA care.  We are not lawyers and cannot give you any legal advice, but would suggest that for further information you discuss this with your Veteran’s service organization or VSO or the Patient Advocate.

Will results of testing be part of my medical record?
Yes. Any blood or other test results for these bacterial infections will be entered into your medical record just like any other laboratory result.

Who will have access to these test results?
Your provider and a limited number of other VA personnel will have access to these results. These test results cannot be released outside of VA without your written permission.

What is VA doing to prevent something like this from happening again?
A thorough investigation is being conducted by US FDA, CDC and VA to understand what happened, and to put in place safeguards so that something like this cannot happen again. While this issue creates potential concerns for you, VA is proud to have a Patient Safety program and remains committed to keeping all our patients informed about anything that could affect their health and well-being.  We apologize for the inconvenience as well as any worry you may have experienced about this issue.  We want you to feel confident that VA will always do the right thing on your behalf and continue to feel confident and trust the care you receive through VA.